Intermittent Hypoxia to Enhance Motor Function After Spinal Cord Injury
Acute Intermittent Hypoxia to Enhance Motor Function After Spinal Cord Injury
1 other identifier
interventional
17
1 country
2
Brief Summary
This study will examine if acute intermittent hypoxia (brief episodes of breathing lower oxygen), which has been shown to enhance plasticity and motor output, can enhance functional outcomes and muscle activation in individuals with spinal cord injury. Our aim is to assess breathing, sitting, standing and walking functional ability before and after acute intermittent hypoxia, compared to a sham treatment. This information may be useful in advancing rehabilitation for people with spinal cord injuries.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2017
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 20, 2017
CompletedFirst Posted
Study publicly available on registry
March 6, 2017
CompletedStudy Start
First participant enrolled
July 10, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2020
CompletedResults Posted
Study results publicly available
November 18, 2023
CompletedNovember 18, 2023
December 1, 2021
3.1 years
February 20, 2017
December 5, 2021
October 27, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Change in Maximal Inspiratory Pressure
An assessment of inspiratory muscle strength.
Change between baseline and 30 minutes post-intermittent hypoxia or sham.
Change in Maximal Expiratory Pressure
An assessment of expiratory muscle strength.
Change between baseline and 30 minutes post-intermittent hypoxia or sham.
Change in Forced Vital Capacity
An assessment of how much air a person can forcefully exhale after a maximal inspiratory effort.
Change between baseline and 30 minutes post-intermittent hypoxia or sham.
Change in Mouth Occlusion Pressure (P0.1)
An assessment of the pressure generated in the first 0.1 seconds of the participant's initiation of inhalation.
Change between baseline and 30 minutes post-intermittent hypoxia or sham.
Study Arms (2)
Acute Intermittent Hypoxia, then Sham Intermittent Hypoxia
EXPERIMENTALSubjects with chronic spinal cord injury first received an acute intermittent hypoxia protocol with low oxygen air (9-15% inspired oxygen). After a washout period of at least one week, they then received sham intermittent hypoxia with normal oxygen air (21% inspired oxygen).
Sham Intermittent Hypoxia, then Acute Intermittent Hypoxia
EXPERIMENTALSubjects with chronic spinal cord injury first received a sham (placebo) intermittent hypoxia protocol with normal oxygen air (21% inspired oxygen). After a washout period of at least one week, they then received an acute intermittent hypoxia protocol with low oxygen air (9-15% inspired oxygen).
Interventions
During acute intermittent hypoxia, subjects will undergo 15 brief exposures (60-120 seconds) of low oxygen air (9-15% inspired oxygen) delivered by an air generator, alternated with 15 brief exposures (60-120 seconds) of ambient room air.
During sham intermittent hypoxia, subjects will undergo 15 brief exposures (60-120 seconds) of normal oxygen air (21% inspired oxygen) delivered by an air generator, alternated with 15 brief exposures (60-120 seconds) of ambient room air.
Eligibility Criteria
You may qualify if:
- Male or female, ages 18-65
- Greater than 6 months post-spinal cord injury
- Spinal cord injury affecting segments between C4-T12
- No other known neurological disorders
- Able to provide informed consent
- no severe musculoskeletal impairments, open wounds, or skin lesions that would limit participation in functional assessments.
You may not qualify if:
- Presence of a self-reported uncontrolled medical condition including, but not limited to: cardiovascular disease; sleep apnea; obstructive lung disease; severe neuropathic or chronic pain; severe recurrent autonomic dysreflexia
- Severe, untreated bladder or urinary tract infection
- Presence of severe musculoskeletal impairments, open wounds, or skin lesions that would limit participation in functional assessments
- Women who report being pregnant or test positive on a pregnancy test
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
University of Florida
Gainesville, Florida, 32611, United States
Brooks Rehabilitation
Jacksonville, Florida, 32216, United States
Related Publications (6)
Gonzalez-Rothi EJ, Lee KZ, Dale EA, Reier PJ, Mitchell GS, Fuller DD. Intermittent hypoxia and neurorehabilitation. J Appl Physiol (1985). 2015 Dec 15;119(12):1455-65. doi: 10.1152/japplphysiol.00235.2015. Epub 2015 May 21.
PMID: 25997947BACKGROUNDHayes HB, Jayaraman A, Herrmann M, Mitchell GS, Rymer WZ, Trumbower RD. Daily intermittent hypoxia enhances walking after chronic spinal cord injury: a randomized trial. Neurology. 2014 Jan 14;82(2):104-13. doi: 10.1212/01.WNL.0000437416.34298.43. Epub 2013 Nov 27.
PMID: 24285617BACKGROUNDTrumbower RD, Jayaraman A, Mitchell GS, Rymer WZ. Exposure to acute intermittent hypoxia augments somatic motor function in humans with incomplete spinal cord injury. Neurorehabil Neural Repair. 2012 Feb;26(2):163-72. doi: 10.1177/1545968311412055. Epub 2011 Aug 5.
PMID: 21821826BACKGROUNDTester NJ, Fuller DD, Fromm JS, Spiess MR, Behrman AL, Mateika JH. Long-term facilitation of ventilation in humans with chronic spinal cord injury. Am J Respir Crit Care Med. 2014 Jan 1;189(1):57-65. doi: 10.1164/rccm.201305-0848OC.
PMID: 24224903BACKGROUNDSatriotomo I, Nichols NL, Dale EA, Emery AT, Dahlberg JM, Mitchell GS. Repetitive acute intermittent hypoxia increases growth/neurotrophic factor expression in non-respiratory motor neurons. Neuroscience. 2016 May 13;322:479-88. doi: 10.1016/j.neuroscience.2016.02.060. Epub 2016 Mar 2.
PMID: 26944605BACKGROUNDSutor T, Cavka K, Vose AK, Welch JF, Davenport P, Fuller DD, Mitchell GS, Fox EJ. Single-session effects of acute intermittent hypoxia on breathing function after human spinal cord injury. Exp Neurol. 2021 Aug;342:113735. doi: 10.1016/j.expneurol.2021.113735. Epub 2021 May 2.
PMID: 33951477RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Emily Fox, Principal Investigator
- Organization
- University of Florida
Study Officials
- PRINCIPAL INVESTIGATOR
Emily J Fox, MHS, DPT, PhD
University of Florida
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- Subjects will be asked to participate in two visits at least 7 days apart. Subjects will be assessed on various clinical outcomes before and after an exposure to one of two treatments. In one visit, subjects will be assessed before and after acute intermittent hypoxia, consisting of brief exposures of breathing low oxygen air, alternated with brief exposures to room air. In the other visit, subjects will be assessed before and after an exposure to a sham treatment, consisting of breathing brief exposures of normal oxygen air, alternated with brief exposures to room air. Subjects will undergo acute intermittent hypoxia or a sham treatment in a randomized order.
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 20, 2017
First Posted
March 6, 2017
Study Start
July 10, 2017
Primary Completion
September 1, 2020
Study Completion
September 1, 2020
Last Updated
November 18, 2023
Results First Posted
November 18, 2023
Record last verified: 2021-12
Data Sharing
- IPD Sharing
- Will not share